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NIAID HIV and Emerging Infectious Diseases Program

AVI-7100 Study

Study name

A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects

Study number

13-I-0029

Goal of the Study

The primary goal of this study is to evaluate a new anti-viral drug called AVI-7100 that might have activity against the influenza virus. This drug is being studied and has not been approved by the Food and Drug Administration (FDA). This drug is given through a vein (IV), and is not like any of the drugs currently available for influenza. The drug binds to the genetic material of the virus and may keep a person who takes the drug from having a more serious case of the flu.

The purpose of this study is to learn how safe and how well tolerated this medication may be. The medication has only been given to 6 humans so far. In those people it was well tolerated (one person had a headache), but it was given at very low doses. This study will give increasingly larger doses until we reach the largest dose we have planned to test, or until the people who are receiving the drug have side effects that limit going any farther. Then it will be given to people in multiple doses. This means that people who join this study later on will be getting larger doses of the drug, and may get the drug several times, instead of only once.

Study Regimen

We will recruit 40 subjects for the single-dose cohort, and 24 subjects for the cohort later. The investigational drug is administered by IV, and that visit requires at least a 12 hour stay. Additional visits include physical exams and blood draws. There will be about six visits required in about a one month period. Volunteers will be compensated.

Eligibility Criteria

You are between the ages of 18-60

You are willing to have an IV-administered, investigational study drug

You are not a smoker

You do not take any medications (only Tylenol, oral contraceptives, vitamins, and some seasonal allergy drugs are allowed)

You do not have any significant medical problems or illnesses

You have not donated blood in the last 30 days

You have not received blood products in the past 60 days

You are you able to spend about 12 hours at the NIH for one of the study visits